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This study aims to evaluate the pharmacokinetic interaction between tegoprazan and combination of metronidazole, tetracycline and bismuth in healthy adult volunteers.
A open-label, randomized, multiple dose, two arm, two period, crossover study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tegoprazan 50 mg | Active Comparator | Oral administration of Tegoprazan 50 mg twice daily for 7 days |
|
| Tegoprazan 50 mg+MTN 500 mg+TCL 500 mg+BIS 300 mg | Active Comparator | Oral administration of Tegoprazan 50 mg twice daily, Metronidazole 500 mg three times daily, and Tetracycline hydrochloride 500 mg & Tripotassium bismuth dicitrate 300 mg four times daily for 7 days |
|
| MTN 500 mg+TCL 500 mg+BIS 300 mg | Active Comparator | Oral administration of Metronidazole 500 mg twice daily, Tetracycline hydrochloride 500 mg & Tripotassium bismuth dicitrate 300 mg four times daily for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tegoprazan | Drug | Tegoprazan 50 mg tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-12 of tegaprazan and metabolite M1 | Area under the plasma concentration versus time curve of tegoprazan | pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in period1 ,2. |
| Cmax of tegaprazan and metabolite M1 | Peak Plasma Concentration of tegoprazan and metabolite M1 | pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in period1 ,2. |
| AUC0-6 of metronidazole, tetracycline and bismuth | Area under the plasma concentration versus time curve of metronidazole, tetracycline and bismuth | pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in period1 ,2. |
| Cmax of metronidazole, tetracycline and bismuth | Peak Plasma Concentration of metronidazole, tetracycline and bismuth | pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in period1 ,2. |
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Inclusion Criteria:
Exclusion Criteria:
Medical History
Laboratory tests(in blood)
1) Total bilirubin, AST (GOT), ALT (GPT) > 1.5 X upper limit of normal (ULN) at screening
History of drug/alcohol abuse
Participated in other study and received investigational product within 3 months prior to the first study dose.
taken a medication known to substantially induce or inhibit a drug metabolizing enzyme
Not able to use a medically acceptable contraceptive method throughout the study.
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| Name | Affiliation | Role |
|---|---|---|
| Min-Gul Kim, MD | Chonbuk university hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chonbuk National University Hospital | Jeonju | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33637332 | Derived | Jeon JY, Kim SY, Moon SJ, Oh K, Lee J, Kim B, Song GS, Kim MG. Pharmacokinetic Interactions between Tegoprazan and Metronidazole/Tetracycline/Bismuth and Safety Assessment in Healthy Korean Male Subjects. Clin Ther. 2021 Apr;43(4):722-734. doi: 10.1016/j.clinthera.2021.01.026. Epub 2021 Feb 23. |
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| ID | Term |
|---|---|
| C000631239 | tegoprazan |
| D008795 | Metronidazole |
| D013752 | Tetracycline |
| D001729 | Bismuth |
| C002791 | bismuth tripotassium dicitrate |
| ID | Term |
|---|---|
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
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| Metronidazole | Drug | Metronidazole 250 mg tablet |
|
|
| Tetracycline | Drug | Tetracycline hydrochloride 250 mg capsule |
|
|
| Bismuth | Drug | Tripotassium bismuth dicitrate 300 mg tablet |
|
|
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D004603 | Elements, Radioactive |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D019216 | Metals, Heavy |
| D011868 | Radioisotopes |
| D007554 | Isotopes |
| D008670 | Metals |